NCT06931769Recruiting
TAO-Towards Optimal (Neo)Adjuvant Systemic Therapy of Stage III Triple-negative Breast Cancer
Source: ClinicalTrials.gov · Last updated 7 Oct 2026
Brief summary (registry, in English)
This prospective, national, multi-centre study will include patients with stage III triple-negative breast cancer (TNBC) who are planned to start with standard (neo)adjuvant systemic treatment. The study will gather clinico-pathological, treatment and follow-up information of participating patients through Dutch databases. Participating patients will be asked to complete cancer specific and more generic quality of life questionnaires at nine time points during and after their anticancer treatment in a mobile application. For all patients who have consented to additional blood collection, to assess the course of dynamic ctDNA during (neo)adjuvant chemotherapy and its relation with outcome, two tubes will be collected at four different time points.
- Status (registry)
- Recruiting
- Study type
- Observational
- Enrollment
- 100 (estimated)
- First submitted
- 28 Oct 2024
- Start date
- 6 Nov 2025
- Primary completion date
- 1 Jul 2029
- Lead sponsor
- The Netherlands Cancer Institute
- Diseases
- Triple-negative breast cancer
- NCT number
- NCT06931769
What you commit to
- Study type: Observational
- Planned participants: 100
- From 6 Nov 2025 to the primary completion date, 1 Jul 2029
- 9 sites in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Other
- Evidence of distant metastases. Staging examinations should have been performed according to Dutch national guidelines.
- Patients who are only treated systemically in the adjuvant setting
- Participation in another clinical study with an treatment intervention during the course of this study.
Who the study is looking for
- Patients aged 18 years or older
- Histologically confirmed adenocarcinoma of the breast
- Assumed clinical or pathological stage III (TNM) breast cancer
- Breast tumor must be:
- HER2-negative: i.e. either score 0 or 1 at immunohistochemistry or score 2 at immunohistochemistry and negative at in situ hybridization (ISH, CISH or FISH)
- Hormone receptor negative i.e. an estrogen receptor (ER) of \<10% and progesterone receptor (PR) of \<10%.; or in case of a histological grade III tumor an ER of \<50% and a PR of \<50%.
- Patients are planned to receive the complete standard of care in the Netherlands; neo-adjuvant chemotherapy according to local practise
- Participating patients have to be able to use a mobile phone, tablet, laptop and/or computer and understand the Dutch language
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (9)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| The Netherlands Cancer Institute Coordinator of this site? Confirm its status | Amsterdam | Netherlands | Recruiting |
| Amsterdam University Medical Center Coordinator of this site? Confirm its status | Amsterdam | Netherlands | Not yet recruiting |
| Amphia Coordinator of this site? Confirm its status | Breda | Netherlands | Recruiting |
| Deventer Ziekenhuis Coordinator of this site? Confirm its status | Deventer | Netherlands | Not yet recruiting |
| Medical Spectrum Twente Coordinator of this site? Confirm its status | Enschede | Netherlands | Recruiting |
| UMCG Coordinator of this site? Confirm its status | Groningen | Netherlands | Recruiting |
| Maastricht University Medical Center Coordinator of this site? Confirm its status | Maastricht | Netherlands | Recruiting |
| CWZ Coordinator of this site? Confirm its status | Nijmegen | Netherlands | Not yet recruiting |
| ErasmusMC Coordinator of this site? Confirm its status | Rotterdam | Netherlands | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.